BEUDAMED
    FDA Recall Terminated

    Holt Probe Round Straight

    Recall: Z-0540-06 · Initiated December 22, 2005

    Recall

    Recall Number
    Z-0540-06
    Event Number
    34462
    Firm
    Medtronic Sofamor Danek Instrument Manufacturing
    FEI Number
    3004564008
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2005
    Posted
    February 23, 2006
    Terminated
    April 6, 2007
    Address
    2975 Brother Blvd, Bartlett, TN, 38133-3957

    Description

    Holt Probe Round Straight

    Reason

    Depth indicators are incorrectly labeled (etched) on a measurement instrument.

    Action

    The firm notified its direct consignees of the problem with the product and requested the return of any inventory via letter dated 12/22/05.

    Distribution

    Nationwide, Japan, Hong Kong, Australia, The Netherlands Units - Domestic: 31, International: 19

    Quantity

    50 units